Oral Mucosa Wound Healing After Gingival Recession Treatment in Diabetic Patients. A Clinical Study. (NCT07470281) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Oral Mucosa Wound Healing After Gingival Recession Treatment in Diabetic Patients. A Clinical Study.
United States40 participantsStarted 2026-07
Plain-language summary
The goal of this clinical trial is to evaluate local and systemic factors involved in oral mucosal healing after gingival recession treatment in diabetic patients and to compare them with those in non-diabetic patients.
Diabetic and non-diabetic volunteers of both sexes aged ≥ 18 years with gingival recession may participate. The main questions it aims to answer are:
1. If the gingival recession reduction and percentage of root coverage are different in diabetics compared to non-diabetics.
2. If different factors, such as the oral microbiome, inflammatory markers, and others, are associated with the clinical outcome.
Participants will be asked:
* Receive the procedure to treat their gingival recession defects
* To attend follow-up visits at 7, 14, 30, 90, and 180 days after treatment.
* To provide different biological samples
* To answer different questionnaires.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* aged ≥ 18 years;
* non-diabetic and diabetic patients (HbA1c\>7% (American Diabetes Association 2025) managed with oral hypoglycemic agents or insulin;
* in the need of gingival recession treatment (RT1) in upper or lower arches with identifiable or restored cement-enamel junction (CEJ);
* periodontal stable (BoP ≤25%)(Lang et al. 2003);
* no morphological or pathological conditions in the palatal mucosa.
Exclusion Criteria:
* patients with cardiovascular, blood dyscrasias, and immunodeficiency that contraindicate surgical procedures;
* taking medications known to interfere with the wound healing process or that contraindicate the surgical procedure;
* Pregnancy/lactation (assessed via self-report);
* current opportunistic oral lesions that mainly colonize the palate region;
* subjects that have taken antibiotics within the last 3 months or need for antibiotic prophylaxis;
* prisoners;
* signs or symptoms of active extra-oral head and neck infection (swelling) as determined by a dentist at the time of evaluation;
* subjects who cannot read or speak English or Spanish, and do not agree to having the assistance of an interpreter
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.